Table 2.
Performance of the Xpert Bladder Cancer (BC) Monitor and cytology, overall and according to recurrence grade, initial EORTC risk group, and the highest EORTC risk group during NMIBC surveillance
| n/N (%) [95% CI] | Cytology | Xpert BC Monitor | Cytology | Xpert BC Monitor | Cytology | Xpert BC Monitor |
|---|---|---|---|---|---|---|
| Overall | LG recurrences excluded | HG recurrences excluded | ||||
| Sensitivity | 2/26 (7.7) [1.2; 25.5] | 32/44 (72.7) [58.0; 83.7] | 1/9 (11.1) [0.2; 46.0] | 12/13 (92.3) [64.2; 100.0] | 1/17 (5.9) [0.0; 29.3] | 20/31 (64.5) [46.8; 78.9] |
| Specificity | 310/317 (97.8) [95.4; 99.0] | 330/448 (73.7) [69.4; 77.5] | 310/317 (97.8) [95.4; 99.0] | 330/448 (73.7) [69.4; 77.5] | 310/317 (97.8) [95.4; 99.0] | 330/448 (73.7) [69.4; 77.5] |
| PPV | 2/9 (22.2) [0.0; 49.4] | 32/150 (21.3) [14.8; 27.9] | 1/8 (12.5) [0.0; 35.4] | 12/130 (9.2) [4.3; 14.2] | 1/8 (12.5) [0.0; 35.4] | 20/138 (14.5) [8.6; 20.4] |
| NPV | 310/334 (92.8) [90.0; 95.6] | 330/342 (96.5) [94.5; 98.4] | 310/318 (97.5) [95.8; 99.2] | 330/331 (99.7) [99.1; 100.0] | 310/326 (95.1) [92.7; 97.4] | 330/341 (96.8) [94.9; 98.6] |
| High initial EORTC risk | Intermediate initial EORTC risk | Low initial EORTC risk | ||||
|---|---|---|---|---|---|---|
| Sensitivity | 1/9 (11.1) [0.2; 46.0] | 13/15 (86.7) [60.6; 97.3] | 0/4 (0.0) [0.0; 0.0] | 5/5 (100.0) [100.0; 100.0] | 1/11 (9.1) [0.0; 40.2] | 10/20 (50.0) [30.0; 70.0] |
| Specificity | 121/124 (97.6) [92.7; 99.5] | 117/181 (64.6) [57.4; 71.2] | 27/27 (100.0) [100.0; 100.0] | 28/34 (82.4) [66.0; 91.9] | 138/142 (97.2) [92.7; 99.1] | 167/203 (82.3) [76.4; 86.9] |
| PPV | 1/4 (25.0) [0.0; 67.4] | 13/77 (16.9) [8.5; 25.3] | 0/0 (0.0) [0.0; 0.0] | 5/11 (45.5) [16.0; 74.9] | 1/5 (20.0) [0.0; 55.1] | 10/46 (21.7) [9.8; 33.7] |
| NPV | 121/129 (93.8) [89.6; 98.0] | 117/119 (98.3) [96.0; 100.0] | 27/31 (87.1) [75.3; 98.9] | 28/28 (100.0) [100.0; 100.0] | 138/148 (93.2) [89.2; 97.3] | 167/177 (94.4) [90.9; 97.8] |
| Highest EORTC risk: high | Highest EORTC risk: intermediate | Highest EORTC risk: low | ||||
|---|---|---|---|---|---|---|
| Sensitivity | 1/12 (8.3) [0.0; 37.9] | 16/18 (88.9) [65.7; 97.9] | 0/7 (0.0) [0.0; 0.0] | 8/10 (80.0) [47.8; 95.1] | 1/7 (14.3) [1.0; 53.6] | 6/14 (42.9) [21.5; 67.4] |
| Specificity | 149/152 (98.0) [94.0; 99.6] | 137/214 (64.0) [57.4; 70.1] | 53/53 (100.0) [100.0; 100.0] | 55/68 (80.9) [69.8; 88.5] | 100/104 (96.2) [90.1; 98.8] | 131/157 (83.4) [76.8; 88.5] |
| PPV | 1/4 (25.0) [0.0; 67.4] | 16/93 (17.2) [9.5; 24.9] | 0/0 (0.0) [0.0; 0.0] | 8/21 (38.1) [17.3; 58.9] | 1/5 (20.0) [0.0; 55.1] | 6/32 (18.8) [5.2; 32.3] |
| NPV | 149/160 (93.1) [89.2; 97.0] | 137/139 (98.6) [96.6; 100.0] | 53/60 (88.3) [80.2; 96.5] | 55/57 (96.5) [91.7; 100.0] | 100/106 (94.3) [89.9; 98.7] | 131/139 (94.2) [90.4; 98.1] |
CI confidence interval, HG high-grade, LG low-grade, NPV negative predictive value, PPV positive predictive value